Lymphedema of Upper ArmLYMphoNIGHTNCT04203069
Auto-Adjustable MOBIDERM® Autofit NIGHT-time Compression Armsleeve in the Upper Limb LYMphedema in Maintenance Phase
A study testing Intervention group : Day-time compression sleeve and Night-time MOBIDERM® Autofit in people with Lymphedema of Upper Arm, run by Thuasne at 8 sites in 2 countries.
Trial summary
This study aims to assess Auto-Adjustable MOBIDERM® Autofit Armsleeve effect on upper limb volume excess after 3 months of maintenance phase treatment in patients with secondary upper limb lymphedema following breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Lymphedema of Upper Arm
- What is being tested?
- Intervention group : Day-time compression sleeve and Night-time MOBIDERM® Autofit
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 63 participants
- Where
- 8 sitesin 2 countries
- Study dates
- 1 Jul 2020to 15 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women responding positively to the lymphedema reduction phase defined by a ≥ 20% decrease in lymphedema volume at the end of DLT
- Unilateral secondary upper limb lymphedema of stage II or III according to the criteria defined by the International Society of Lymphology, following breast cancer
- Affected arm that fits with one of the 6 standard sizes of the Auto-Adjustable MOBIDERM® Autofit armsleeve provided
- Signed informed consent prior to any study-mandated procedure
- Affiliated to the General regime of the Social Security or covered by a similar health insurance system
- Non-inclusion criteria :
Show all 17Show fewer
- Stage I lymphedema or located in several places
- Active cellulitis / Infectious dermo-hypodermatitis
- Lymphedema associated with active cancer needing acute chemotherapy
- Motor and sensitive neurological deficiency / psychiatric or addictive disorders
- Post-operative edema (i.e acute edema occurring during the days following breast cancer-related surgery)
- Patients for whom compression is contraindicated, such as untreated infections, skin irritation, thrombosis, presence of skin lesions on the armsleeve placement
- Pregnant or breastfeeding patient
- Previous history of hypersensitivity to MOBIDERM® technology or lymphatrex garment General conditions
- Participation to any other clinical study which has an impact on the different endpoints
- Unlikely to be followed up to 3 months with clinical assessment as per investigator's judgment
- Vulnerable patient according to the article L.1121-6 of the French Public Health Code, the adults being the object of a legal protective measure or enable to express their consent according to the article L.1121-8 of French Public Health Code
Who cannot join
None listed.
Trial locations and contacts
8 sites in 2 countries.
8 sites in 2 countries
France7 sites
Chu Grenoble
Grenoble
Chu Montpellier
Montpellier
Ghr Mulhouse
Mulhouse
CHU NICE
Nice
Nimes
Nîmes
Chu Toulouse
Toulouse
CHRU Tours
Tours, 37044
About this study
Official title: Multicenter, Controlled, Randomized, Open Label, Clinical Study to Assess the Efficacy of Auto-Adjustable MOBIDERM® Autofit NIGHT-time Compression Armsleeve in the Management of Upper Limb LYMphedema in Maintenance Phase: LYMphoNIGHT Study
This study aims to assess Auto-Adjustable MOBIDERM® Autofit Armsleeve effect on upper limb volume excess after 3 months of maintenance phase treatment in patients with secondary upper limb lymphedema following breast cancer.
Half of the patient will wear a day-time and night time compression garment (MOBIDERM Autofit) for 3 months during the maintenance phase, while the other half will only wear day-time compression garment.
Read the detailed description
The gold standard treatment to achieve volume reduction of lymphedema is based on a Decongestive Lymphedema Therapy (DLT).that consists in 2 consecutive phases: the initial intensive phase which aim is to obtain maximal reduction of lymphedema volume and a second, the maintenance phase which aim is to maintain the initial volumetric reduction achieved during phase 1 as long as possible. The second maintenance phase mostly based on patient self-management of his treatment, is not strictly codified, but includes compression therapy, nutritional recommendations, skin cares, physical exercises and manual lymphatic drainage.
24 hours compression using garments or bandages seems to be crucial for long term management of lymphedema.
Garment and bandages prescriptions for daily treatment are a common practice in the maintenance phase but are often unsuitable for night treatment, as bandages are effective when well applied but are highly dependent on the patients' skills, and garments, due to their nature, can be poorly tolerated leading to low adherence from patients to self-management care. In the end, there is an unmet medical need for night treatment during maintenance phase. .
In this context THUASNE developed a specific night-time garment, for lymphedema maintenance phase. It is a standard Auto-Adjustable Armsleeve using the MOBIDERM® technology.
MOBIDERM® AUTOFIT is a standard self-adjusting compressive MOBIDERM® sleeve, with mitten.
Several small rigid straps are placed throughout the product to facilitate the passage of the arm, to adapt the garment to the morphology of each patient and to tighten it.
A first pilot randomized controlled study demonstrated some benefit to use MOBIDERM Autofit during night-time as an adjuvant treatment to daily compressive garment.
The objective of this new study is to confirm, using a more robust methodology, the effect of Auto-Adjustable MOBIDERM® Autofit Armsleeve on maintenance phase treatment, worn during the night, within the period at risk for the so called rebound effect as reported in several observational studies.
- Conditions
- Lymphedema of Upper Arm
- Being tested
- Control group : Day-time compression sleeve, Intervention group : Day-time compression sleeve and Night-time MOBIDERM® Autofit
- Keywords
- Lymphedema of upper arm, Auto-Adjustable MOBIDERM® Autofit Armsleeve, Compression garments, Maintenance phase
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control group : Day-time compression sleeveDevice
In the control group, patients wear only day-time compression garment : lymphatrex during 3 months.
The protocol will require 3 visits during the maintenance phase.
Visit 1 at day 0 (until 5 days after the end of hospital): includes the inclusion visit with the reception of devices and some evaluations (clinical examination, lymphedema volume, questionnaires, ultrasound on a patients sub-group).
Visit 2 at 30 days after the inclusion : includes some evaluations (clinical examination, lymphedema volume, questionnaires, ultrasound on a patients sub-group)
Visite 3 at 90 days after the inclusion : includes some evaluations (clinical examination, lymphedema volume, questionnaires, ultrasound on a patients sub-group).
Intervention group : Day-time compression sleeve and Night-time MOBIDERM® AutofitDevice
In the intervention group, patients wear a day-time compression garment : lymphatrex and the night-time compression garment : MOBIDERM AUTOFIT during 3 months.
The protocol will require 3 visits during the maintenance phase.
Visit 1 at day 0 (until 5 days after the end of hospital): includes the inclusion visit with the reception of devices and some evaluations (clinical examination, lymphedema volume, questionnaires, ultrasound on a patients sub-group).
Visit 2 at 30 days after the inclusion : includes some evaluations (clinical examination, lymphedema volume, questionnaires, ultrasound on a patients sub-group)
Visite 3 at 90 days after the inclusion : includes some evaluations (clinical examination, lymphedema volume, questionnaires, ultrasound on a patients sub-group).
| Study group | Role | What they receive |
|---|---|---|
| Control group : Day-time compression sleeve | Placebo comparator | Control group : Patients will wear the Day-time compression sleeve : THUASNE lymphatrex (± mitten) during 90 days. Receives: Device: Control group : Day-time compression sleeve |
| Day-time compression sleeve and Night-time MOBIDERM Autofit | Experimental | Intervention group : Patients will wear the Day-time compression sleeve : THUASNE lymphatrex (± mitten) + night-time Auto-Adjustable MOBIDERM® Autofit Armsleeve device with the possibility to wear an additional MOBIDERM® glove if a patient has a finger edema during 90 days. Receives: Device: Intervention group : Day-time compression sleeve and Night-time MOBIDERM® Autofit |
What is being measured
The primary outcome is the main question the study is designed to answer.
The volume excess variation
The primary endpoint of this study is to compare the volume excess variation of the upper limb between both groups from D0 to D90. Volume excess is defined as the volumetric difference between the affected upper limb compared to the contralateral upper limb, calculated with truncated cone formula.
Measured: 90 days
Secondary outcomes (14)
The quality of life (QoL): LYMQOL ARM self-questionnaire
The evolution of QoL is measured by LYMQOL ARM self-questionnaire and specific questions. This tool was designed as patient-completed questionnaire. The questions cover four domains : symptoms, body image/appearance, function, mood. Each item in each domain was scored : not at all (1), a little (2), Quite a bit (3), A lot (4). Specific questions are about patient's perception of benefit.
Measured: 30 and 90 days
The range of motion
The evolution of range of motion of the arm is measured by joint movements : Antepulsion (flexion), retropulsion (extension), total abduction, adduction, lateral rotation (external rotation), medial rotation (internal rotation)
Measured: 30 and 90 days
The volume excess variation
Volume excess is defined as the volumetric difference between the affected upper limb compared to the contralateral upper limb, calculated with truncated cone formula.
Measured: 30 days
Patient's opinion on Global Impression of Change (PGI-C)
Patient's opinion on Global Impression of Change about her general condition is measured by the modified PGI-C questionnaire (Patient's opinion on Global Impression of Change). The scale has 7 levels from "no change or condition has got worsed"(worse outcome) to "a great deal better, and a considerable improvement that has made all the difference ( better outcome)". Intermediate levels are: "almost the same, hardly any change at all"; "a little better, but no noticeable change", "somewhat better, but the change has not made any real difference"; "moderately better, and a slight but noticeable change"; "better, and a definite improvement that has made a real and worthwhile difference.
Measured: 30 and 90 days
Doctors' opinion on improving the patient's health condition (Clinical Global Improvement Impression)
Doctors' opinion on improving the patient's health condition caused by lymphedema is measured by the CGI-I modified questionnaire (Clinical Global Improvement Impression). This questionnaire allows doctors to evaluate the improvement of patients. The scale has 7 levels from "very strongly improved"(better outcome) to "very strongly aggravated"(worse outcome).Intermediate levels are: " Significantly improved " ; " Slightly improved " ; " No improvement " ; " Slightly aggravated " ; " Seriously aggravated ".
Measured: 30 and 90 days
Doctors' opinion on severity about the lymphedema (CGI-S)
Doctors' opinion on severity about the lymphedema is measured by CGI-S. This questionnaire assesses the severity of lymphedema. This scale has 7 levels from "normal, not sick at all" (better outcome) to " among the most severely ill patients "(worse outcome). Intermediate levels are: " borderline ill " ; " slightly ill " ; " moderately ill " ; " clearly ill " ; " severely ill ".
Measured: 30 and 90 days
number of days/nights : The compliance to treatment
The compliance to treatment (day-time and night-time only for Intervention Group) is reported by the physician in the e-CRF according to the patient diary. The compliance is measured in number of days and or nights (groupe I) when the device was worn and the average wearing time was : Full day/night, >50% of the day/night,<50% of the day/night
Measured: 30 and 90 days
The evolution of quality of sleep: Jenkins self-questionnaire
The evolution of quality of sleep is measured by Jenkins self-questionnaire. This scale is composed of four questions about the quality of sleep.
Measured: 30 and 90 days
The satisfaction about the device: questionnaire
Patient's satisfaction with regards to MOBIDERM® Autofit for patients from intervention group only by a satisfaction questionnaire. This questionnaire is focused on the product positioning and the comfort.
Measured: 90 days
Number and type of serious and non-serious Adverse Device Effects
Number and type of serious and non-serious Adverse Device Effects (ADE) with a focus on cutaneous ADE will be reported during the study.
Measured: 90 days
The elastometry
To compare the evolution of skin thickness, elasticity, suppleness on a subgroup of patients by ultrasound.
Measured: 30 and 90 days
The percentage of patients presenting with a failure of maintenance
Percentage of patients presenting with a failure of maintenance phase, defined by a volume increase ≥ 30% of the volume reduction observed during intensive phase of decongestive lymphedema therapy (DLT)
Measured: 30 and 90 days
The satisfaction about the daytime device: questionnaire
Patient's satisfaction with regards to daytime device for all patients by a satisfaction questionnaire. This questionnaire is focused on the product positioning and the comfort.
Measured: 90 days
The quality of life (QoL): EQ-5D-5L self-questionnaire
The evolution of QoL is measured by EQ5D 5L self-questionnaire. This tool was designed as patient-completed questionnaire. The questions cover five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems.
Measured: 30 and 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2019
- Study start1 Jul 2020
- Primary completion30 Dec 2023
- Study completion15 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Lymphedema of Upper ArmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective open-label RIPH 2 study multicenter, controlled, randomized, with two parallel groups.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thuasne
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- International Clinical Trials Association
- Responsible party
- Sponsor
- Investigators
- ISABELLE QUERE, PUPH,MD, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04203069
- Sponsor's protocol ID
- EC29
- Other IDs
- ANSM
- Acronym
- LYMphoNIGHT
- Status last verified
- Sep 2024
- First submitted
- 16 Dec 2019
- Last updated
- 23 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Quere I, Presles E, Coupe M, Vignes S, Vaillant L, Eveno D, Laporte S, Leizorovicz A; POLIT Study investigators. Prospective multicentre observational study of lymphedema therapy: POLIT study. J Mal Vasc. 2014 Jul;39(4):256-63. doi: 10.1016/j.jmv.2014.05.004. Epub 2014 Jun 12.
PubMed 24931830Mestre S, Calais C, Gaillard G, Nou M, Pasqualini M, Ben Amor C, Quere I. Interest of an auto-adjustable nighttime compression sleeve (MOBIDERM(R) Autofit) in maintenance phase of upper limb lymphedema: the MARILYN pilot RCT. Support Care Cancer. 2017 Aug;25(8):2455-2462. doi: 10.1007/s00520-017-3652-5. Epub 2017 Mar 9.
PubMed 28281052Brown JC, Cheville AL, Tchou JC, Harris SR, Schmitz KH. Prescription and adherence to lymphedema self-care modalities among women with breast cancer-related lymphedema. Support Care Cancer. 2014 Jan;22(1):135-43. doi: 10.1007/s00520-013-1962-9. Epub 2013 Sep 7.
PubMed 24013569Borman P, Mestre S, Cakit BD, Giordana P, Atar B, Vernhet E, Blaise S, Quere I. Night-time compression with a Mobiderm(R) auto-adjustable arm-sleeve in addition to daytime compression was superior to daytime compression alone for maintenance therapy of upper limb lymphedema in breast cancer patients in a randomized controlled trial: LYMphoNIGHT study. Support Care Cancer. 2026 May 7;34(6):512. doi: 10.1007/s00520-026-10735-6.
PubMed 42091704
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Controlled, Randomized, Open Label, Clinical Study to Assess the Efficacy of Auto-Adjustable MOBIDERM® Autofit NIGHT-time Compression Armsleeve in the Management of Upper Limb LYMphedema in Maintenance Phase: LYMphoNIGHT Study
- ClinicalTrials.gov ID
- NCT04203069
- Acronym / sponsor ID
- LYMphoNIGHT / EC29
- Conditions
- Lymphedema of Upper Arm
- Keywords
- Lymphedema of upper arm, Auto-Adjustable MOBIDERM® Autofit Armsleeve, Compression garments, Maintenance phase
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- ThuasneIndustry (pharma, biotech, devices)
- Collaborators
- International Clinical Trials Association
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 30 Dec 2023 (actual)
- Study completion
- 15 Sep 2024 (actual)
- First posted
- 18 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to assess Auto-Adjustable MOBIDERM® Autofit Armsleeve effect on upper limb volume excess after 3 months of maintenance phase treatment in patients with secondary upper limb lymphedema following breast cancer.
Half of the patient will wear a day-time and night time compression garment (MOBIDERM Autofit) for 3 months during the maintenance phase, while the other half will only wear day-time compression garment.
Detailed description
The gold standard treatment to achieve volume reduction of lymphedema is based on a Decongestive Lymphedema Therapy (DLT).that consists in 2 consecutive phases: the initial intensive phase which aim is to obtain maximal reduction of lymphedema volume and a second, the maintenance phase which aim is to maintain the initial volumetric reduction achieved during phase 1 as long as possible. The second maintenance phase mostly based on patient self-management of his treatment, is not strictly codified, but includes compression therapy, nutritional recommendations, skin cares, physical exercises and manual lymphatic drainage.
24 hours compression using garments or bandages seems to be crucial for long term management of lymphedema.
Garment and bandages prescriptions for daily treatment are a common practice in the maintenance phase but are often unsuitable for night treatment, as bandages are effective when well applied but are highly dependent on the patients' skills, and garments, due to their nature, can be poorly tolerated leading to low adherence from patients to self-management care. In the end, there is an unmet medical need for night treatment during maintenance phase. .
In this context THUASNE developed a specific night-time garment, for lymphedema maintenance phase. It is a standard Auto-Adjustable Armsleeve using the MOBIDERM® technology.
MOBIDERM® AUTOFIT is a standard self-adjusting compressive MOBIDERM® sleeve, with mitten.
Several small rigid straps are placed throughout the product to facilitate the passage of the arm, to adapt the garment to the morphology of each patient and to tighten it.
A first pilot randomized controlled study demonstrated some benefit to use MOBIDERM Autofit during night-time as an adjuvant treatment to daily compressive garment.
The objective of this new study is to confirm, using a more robust methodology, the effect of Auto-Adjustable MOBIDERM® Autofit Armsleeve on maintenance phase treatment, worn during the night, within the period at risk for the so called rebound effect as reported in several observational studies.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective open-label RIPH 2 study multicenter, controlled, randomized, with two parallel groups.
| Arm | Type | Receives |
|---|---|---|
| Control group : Day-time compression sleeve | Placebo comparator | Device: Control group : Day-time compression sleeveControl group : Patients will wear the Day-time compression sleeve : THUASNE lymphatrex (± mitten) during 90 days. |
| Day-time compression sleeve and Night-time MOBIDERM Autofit | Experimental | Device: Intervention group : Day-time compression sleeve and Night-time MOBIDERM® AutofitIntervention group : Patients will wear the Day-time compression sleeve : THUASNE lymphatrex (± mitten) + night-time Auto-Adjustable MOBIDERM® Autofit Armsleeve device with the possibility to wear an additional MOBIDERM® glove if a patient has a finger edema during 90 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Women responding positively to the lymphedema reduction phase defined by a ≥ 20% decrease in lymphedema volume at the end of DLT
- Unilateral secondary upper limb lymphedema of stage II or III according to the criteria defined by the International Society of Lymphology, following breast cancer
- Affected arm that fits with one of the 6 standard sizes of the Auto-Adjustable MOBIDERM® Autofit armsleeve provided
- Signed informed consent prior to any study-mandated procedure
- Affiliated to the General regime of the Social Security or covered by a similar health insurance system
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Control group : Day-time compression sleeveIn the control group, patients wear only day-time compression garment : lymphatrex during 3 months. The protocol will require 3 visits during the maintenance phase. Visit 1 at day 0 (until 5 days after the end of hospital): includes the inclusion visit with the reception of devices and some evaluations (clinical examination, lymphedema volume, questionnaires, ultrasound on a patients sub-group). Visit 2 at 30 days after the inclusion : includes some evaluations (clinical examination, lymphedema volume, questionnaires, ultrasound on a patients sub-group) Visite 3 at 90 days after the inclusion : includes some evaluations (clinical examination, lymphedema volume, questionnaires, ultrasound on a patients sub-group). | Device | Control group : Day-time compression sleeve |
| Intervention group : Day-time compression sleeve and Night-time MOBIDERM® AutofitIn the intervention group, patients wear a day-time compression garment : lymphatrex and the night-time compression garment : MOBIDERM AUTOFIT during 3 months. The protocol will require 3 visits during the maintenance phase. Visit 1 at day 0 (until 5 days after the end of hospital): includes the inclusion visit with the reception of devices and some evaluations (clinical examination, lymphedema volume, questionnaires, ultrasound on a patients sub-group). Visit 2 at 30 days after the inclusion : includes some evaluations (clinical examination, lymphedema volume, questionnaires, ultrasound on a patients sub-group) Visite 3 at 90 days after the inclusion : includes some evaluations (clinical examination, lymphedema volume, questionnaires, ultrasound on a patients sub-group). | Device | Day-time compression sleeve and Night-time MOBIDERM Autofit |
Primary outcome
The volume excess variation
Time frame: 90 days
The primary endpoint of this study is to compare the volume excess variation of the upper limb between both groups from D0 to D90. Volume excess is defined as the volumetric difference between the affected upper limb compared to the contralateral upper limb, calculated with truncated cone formula.
14 secondary outcomes
The quality of life (QoL): LYMQOL ARM self-questionnaire
Time frame: 30 and 90 days
The range of motion
Time frame: 30 and 90 days
The volume excess variation
Time frame: 30 days
Patient's opinion on Global Impression of Change (PGI-C)
Time frame: 30 and 90 days
Doctors' opinion on improving the patient's health condition (Clinical Global Improvement Impression)
Time frame: 30 and 90 days
Doctors' opinion on severity about the lymphedema (CGI-S)
Time frame: 30 and 90 days
number of days/nights : The compliance to treatment
Time frame: 30 and 90 days
The evolution of quality of sleep: Jenkins self-questionnaire
Time frame: 30 and 90 days
The satisfaction about the device: questionnaire
Time frame: 90 days
Number and type of serious and non-serious Adverse Device Effects
Time frame: 90 days
The elastometry
Time frame: 30 and 90 days
The percentage of patients presenting with a failure of maintenance
Time frame: 30 and 90 days
The satisfaction about the daytime device: questionnaire
Time frame: 90 days
The quality of life (QoL): EQ-5D-5L self-questionnaire
Time frame: 30 and 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2024.
- Background: PubMed 24931830Quere I, Presles E, Coupe M, Vignes S, Vaillant L, Eveno D, Laporte S, Leizorovicz A; POLIT Study investigators. Prospective multicentre observational study of lymphedema therapy: POLIT study. J Mal Vasc. 2014 Jul;39(4):256-63. doi: 10.1016/j.jmv.2014.05.004. Epub 2014 Jun 12.
- Background: PubMed 28281052Mestre S, Calais C, Gaillard G, Nou M, Pasqualini M, Ben Amor C, Quere I. Interest of an auto-adjustable nighttime compression sleeve (MOBIDERM(R) Autofit) in maintenance phase of upper limb lymphedema: the MARILYN pilot RCT. Support Care Cancer. 2017 Aug;25(8):2455-2462. doi: 10.1007/s00520-017-3652-5. Epub 2017 Mar 9.
- Background: PubMed 24013569Brown JC, Cheville AL, Tchou JC, Harris SR, Schmitz KH. Prescription and adherence to lymphedema self-care modalities among women with breast cancer-related lymphedema. Support Care Cancer. 2014 Jan;22(1):135-43. doi: 10.1007/s00520-013-1962-9. Epub 2013 Sep 7.
- Derived from this study: PubMed 42091704Borman P, Mestre S, Cakit BD, Giordana P, Atar B, Vernhet E, Blaise S, Quere I. Night-time compression with a Mobiderm(R) auto-adjustable arm-sleeve in addition to daytime compression was superior to daytime compression alone for maintenance therapy of upper limb lymphedema in breast cancer patients in a randomized controlled trial: LYMphoNIGHT study. Support Care Cancer. 2026 May 7;34(6):512. doi: 10.1007/s00520-026-10735-6.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ISABELLE QUERE, PUPH,MD principal investigator
University Hospital, Montpellier
8 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention group : Day-time compression sleeve and Night-time MOBIDERM® Autofit in people with Lymphedema of Upper Arm, run by Thuasne at 8 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in France, Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The volume excess variation (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04203069, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2024.